A Mobile Gaming App to Improve Adherence to PrEP
Rhode Island Hospital · NCT05762705
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 15–34 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 200
- US sites recruiting
- 3
- Study start
- June 21, 2024
- Record last updated
- May 14, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
In this study, the investigators will test the mobile game, Viral Combat, for efficacy and acceptability among diverse participants, ages 15-34 years, receiving PrEP care in clinical settings in New England and Mississippi. Formative evaluation interviews will be conducted with stakeholders (healthcare workers, clinic administrators, and patients taking PrEP) to inform intervention delivery. Data from the formative interviews will also be used to make necessary adaptations to the game and assess acceptability for diverse populations and clinics. Viral Combat will then be further tested with 200 participants ages 15-34 years, receiving PrEP care at clinical sites in the South (n=100 Jackson, MS) and New England (n=100, Providence, RI; Boston, MA) in a multisite Hybrid Type 1 effectiveness-implementation randomized controlled trial (RCT). This trial will test the efficacy of the intervention compared to a control condition (a non-PrEP related game) on biological and behavioral measures. At the end of the trial, a summative evaluation of the implementation context using the i-PARIHS framework will occur. These interviews with study participants and clinic staff will inform future implementation and dissemination of Viral Combat.
Being studied: Multilevel Gaming Adherence Intervention; Treatment as Usual +
Conditions: Medication Adherence; HIV/AIDS
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 15-34 years old
- English speaking
- Initiated PrEP in the last 30 days or re-initiated PrEP after not taking PrEP for at least 1 month
- HIV negative as per clinician and clinical record
- Able to give consent/assent and not impaired by cognitive or medical limitations as per clinical assessment.
Exclusion Criteria
- None
Recruiting US locations
Boston Medical Center
Boston, MA 02118
Site contact: Sharon Vuppula, MD · sharon.vuppula@bmc.org
University of Mississippi Medical Center
Jackson, MS 39216
Site contact: James B Brock, MD · 601-984-5560 · jbbrock@umc.edu
Lifespan (The Miriam Hospital and Rhode Island Hospital)
Providence, RI 02904
Site contact: Larry K Brown, MD · 401-793-8808 · lkbrown@lifespan.org
Study contacts (from the official record)
- Laura Whiteley, MD · (401)-455-6375 · laura_whiteley@brown.edu
- James B Brock, MD · 601-984-5560 · jbbrock@umc.edu
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